Laser marking for medicals industry
International patient safety requirements have led many countries to adopt standards and regulations to identify “Medical Devices” such as contact lenses, bandages, scalpels, syringes, prosthetic in vitro diagnostic devices.
UDI (Unique Device Identifier) coding provides all the standardized information related to the life cycle of the device: from its production to its final use to prove its authenticity.
USA (with Food and Drug Administration FDA regulation), EU (with Medical Devices Regulation MDR 2017/745 and IVDR 2017/746) have passed regulations for medical device identification, and many other countries are passing similar regulations.
Manufacturers must apply specific codes called Unique Device Identifiers (UDI) on all distributed medical devices. The UDI is a unique numeric or alphanumeric code consisting of two parts:
- Device Identifier (UDI- DI). Identifies the specific version or model of a product (mandatory and fixed).
- Production Identifier (UDI- PI, Production Identifier). It is variable and may contain one or more of the following information: Lot number Production date Expiration date Serial number.
This information must be provided either in a human-readable format (alphanumeric text) or in a machine-readable format using Automatic Identification and Data Capture (AIDC) technology.
A UDI code must be placed on the primary packaging and at all upper levels of the device packaging. Since the GTIN (Global Trade Item Number, an identification number issued by GS1) is unique for each level of the device packaging, the UDI code is also unique at any level of the packaging.
In fact, direct marking allows for consistent identification over time, even when a device is no longer accompanied by the label or packaging.
Laser marking is indelible and the contrast is always high. Safer than any other technology, the laser is neither corrosive nor toxic. Laser marking does not compromise component hygiene, and the code resists cleaning with alkaline substances, sterilization at high temperatures, and resists corrosion.